Auditor and Quality Control Expert

4 days ago


Cyberjaya, Selangor, Malaysia Ansell Full time
About Ansell:
Ansell is a global leader in providing health and safety protection solutions that enhance human well-being. Our company operates in two main business segments: Industrial and Healthcare. We continue to grow and employ 14,000 people worldwide.

Job Summary:
We are looking for a highly skilled Quality Assurance Specialist to join our team in Cyberjaya. As a Quality Assurance Specialist, you will carry out QA activities as assigned, supporting organizational goals. This position involves onsite/virtual product inspection/audit, supplier audit, product sample evaluation, and side-by-side comparison. Other tasks include trending analysis, COA review, Change Control coordination, and implementation process management.

Main Responsibilities:
  • Onsite/virtual product inspection/surveillance/audit:
    • Perform product inspections and quality audits of Ansell's manufacturing partners.
    • Maintain appropriate records.
  • Supplier audit:
    • Perform suppliers' quality system audit and/or surveillance per ISO 9001, ISO13485, US FDA 21 CFR 820 Quality System Regulation, and Canada Medical Device Regulation SOR/98-282.
  • Sample Evaluation:
    • Assist in product evaluation/qualification and setup of new products and/or new suppliers.
    • Perform product testing and provide side-by-side product comparison reports.
  • Change Control:
    • Capture change/update on product specifications from time to time.
  • Trending Analysis:
    • Prepare trending charts for routine monitoring and conduct comparison analysis.

Requirements:
Applicants should possess a Bachelor's Degree or equivalent in chemistry/polymer science (preferred) and sufficient work experience in QA, RA, and QMS management. They should also have experience in medical device QARA, such as EN MDR and PPE regulations, all regional/country MD regulations, including gloves standards like ASTM, EN, ISO, JIS, TGA, GB, and etc. Excellent communication skills in English are essential, with fluency in Bahasa Malaysia and Chinese/Mandarin (preferably). Good analytical thinking, problem-solving ability, and flexibility in job rotation are necessary for this role.

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